BOSENTAN SANDOZ bosentan (as monohydrate) 62.5 mg film-coated tablet blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

bosentan monohydrate

Доступно од:

Sandoz Pty Ltd

INN (Међународно име):

bosentan monohydrate

Статус ауторизације:

Registered

Информативни летак

180810-bosentan-cmi
1
BOSENTAN SANDOZ
_bosentan (as monohydrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BOSENTAN
SANDOZ.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BOSENTAN
SANDOZ IS USED FOR
BOSENTAN SANDOZ is used for
the treatment of high blood pressure
in the blood vessels between the
heart and the lungs. This condition is
called pulmonary arterial
hypertension. This medicine acts to
reduce abnormally high blood
pressure by widening these blood
vessels. It belongs to the class of
medicines known as endothelin
receptor antagonists.
Your doctor however, may prescribe
BOSENTAN SANDOZ for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor’s prescription.
BEFORE YOU TAKE
BOSENTAN SANDOZ
_WHEN YOU MUST NOT TAKE _
_BOSENTAN SANDOZ _
DO NOT TAKE THIS MEDICINE IF YOU
ARE:
•
PREGNANT OR INTEND TO BECOME
PREGNANT. YOU MUST STOP TAKING
THE MEDICINE AT LEAST 3 MONTHS
BEFORE TRYING TO BECOME
PREGNANT.
It is known that this medicine
causes harm to the developing
baby if you take it during
pregnancy and in the three
months before becoming
pregnant.
•
BREASTFEEDING:
TELL YOUR DOCTOR IMMEDIATELY IF
YOU ARE BREASTFEEDING.
You are
advised to stop breastfeeding if
this medicine is prescribed for
you because it is not known if this
drug passes into the milk in
women who are taking this
medicine.
•
BEING TREATED WITH CICLOSPORIN A
(a medicine used after a
transplant or to treat psoriasis)
•
BEING TREATED WITH
GLIBENCLAMIDE
(a medicine used for diabetes)
DO NOT TAKE BOSENTAN SANDOZ
IF YOU A

Карактеристике производа

190916-bosentan-sandoz-pi
Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
BOSENTAN SANDOZ
® (BOSENTAN MONOHYDRATE) TABLETS
Bosentan may cause birth defects and is contraindicated in pregnancy.
See Sections 4.3 Contraindications and 4.6 Fertility, pregnancy and
lactation.
Rare cases of hepatic cirrhosis and hepatic failure have been reported
in patients
using Bosentan. See Section 4.4 Special warnings and precautions for
use.
1
NAME OF THE MEDICINE
Bosentan monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each BOSENTAN SANDOZ 62.5 mg film tablet contains 64.541 mg/tablet
bosentan (as
monohydrate), equivalent to 62.5 mg bosentan.
Each BOSENTAN SANDOZ 125 mg film tablet contains 129.082 mg/tablet
bosentan (as
monohydrate), equivalent to 125 mg bosentan.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
BOSENTAN SANDOZ 62.5 mg film tablet is a light orange colour, round,
biconvex film
coated tablet.
BOSENTAN SANDOZ 125 mg film tablet is a light orange colour, oval,
biconvex film tablet.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Bosentan is indicated for the treatment of
•
idiopathic pulmonary arterial hypertension
•
familial pulmonary arterial hypertension
•
pulmonary arterial hypertension associated with scleroderma or
•
pulmonary arterial hypertension associated with congenital systemic to
pulmonary
shunts including Eisenmenger’s physiology
in patients with WHO functional Class II, III or IV symptoms
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Bosentan should be administered under the supervision of a physician
experienced in the
management of Pulmonary Arterial Hypertension (PAH). Bosentan
treatment should be
initiated at a dose of 62.5 mg twice daily for 4 weeks. Efficacy was
demonstrated in clinical
trial subjects who increased to a maintenance dose of 125 mg twice
daily. Doses above 125 mg
twice daily did not appear to confer additional benefit sufficient to
offset the increased risk of
liver injury.
190916-bosentan-sandoz-pi
Page 2 of 28
Serum l